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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Judith Bliss
+44 (0)203 4376647
soprano-icrctsu@icr.ac.uk


Prof Susana Banerjee
+44 (0)20 8661 3463
susana.banerjee@rmh.nhs.uk


Mrs Lorna Smith
+44 (0)20 3437 6647
soprano-icrctsu@icr.ac.uk


Study Location:

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Be Part of Research - Trial Details - SOPRANO - Stereotactic radiotherapy alone or stereotactic radiotherapy follow by niraparib treatment for ovarian cancer with progressive disease in three or less lesions, or recurrence of 3 or less metastatic lesions that had previously achieved complete response.
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SOPRANO - Stereotactic radiotherapy alone or stereotactic radiotherapy follow by niraparib treatment for ovarian cancer with progressive disease in three or less lesions, or recurrence of 3 or less metastatic lesions that had previously achieved complete response.

Recruiting

Open to: Female

Age: Mixed

Leeds Lothian Manchester London London Sutton

Medical Conditions

Oligometastatic or oligoprogressive ovarian, fallopian tube or primary peritoneal carcinoma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Oligometastases or oligoprogression (spreading) of ovarian cancer whilst being treated with a PARP Inhibitor (PARPi) may occur due to a secondary mutation causing resistance to treatment in a small volume of the tumour rather than total tumour resistance. Eradication of the resistant disease with stereotactic radiotherapy (SBRT) would enable the continuation of the PARPi treatment to maintain control of the part of the tumour that has retained drug sensitivity and this has the potential to extend the time to disease progression. The aim of this study is to determine whether the use of SBRT with or without niraparib increases the number of patients without disease progression at 6 months.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

29 Feb 2024 30 Jun 2026

Patients will be randomly allocated to receive either SBRT followed by the PARPi niraparib (cohort 1) or SBRT alone (cohort 2). SBRT will be administered in accordance with the UK SABR consortium guidelines for each site of metastases and will consist of between three and eight fractions of radiotherapy spread over 5 to 19 days. Patients in cohort 1 will then receive niraparib once daily until disease progression (200 or 300 mg depending on weight and blood results). All patients will attend follow-up visits for clinical and imaging assessments every 8 weeks during the first year, reducing to every 12 weeks thereafter until disease progression.


Patients aged 18 years and over with oligometastatic or oligoprogressive ovarian, fallopian tube or primary peritoneal carcinoma.

You can take part if:



You may not be able to take part if:


1. Co-morbidities which would preclude the safe use of SBRT 2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or stereotactic radiosurgery. Previously treated brain metastases (i.e. palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for ≥6 months are permissible3. Prior radiotherapy near the oligometastatic/oligoprogressive lesion precluding ablative SBRT. Suitability of lesions for ablative SBRT as part of the trial defined in section 6.1 of this document and will be determined by the SOPRANO virtual MDT4. Treatment with any other investigational medicinal product within the 4 weeks prior to trial entry5. Pregnant or lactating women6. Women of childbearing age and potential who are not willing to use a highly effective contraceptive measure as detailed in protocol Section 5.57. Any unresolved toxicities from prior therapy should be no greater than CTCAE Grade 1 with the exception of Grade 2 alopecia or chemo-induced neuropathy at trial entry8. Clinical/radiological evidence of bowel obstruction (e.g. hospitalisation) or symptoms of sub-acute bowel obstruction within 6 weeks prior to trial entry9. Any other malignancy which has been active or treated within the past 3 years, with the exception of non-melanoma skin cancer. If prior treatment for another malignancy has taken place, then confirmation of ovarian/fallopian tube/peritoneal cancer progression is required e.g. biopsy, and discussion with the Chief Investigator and SBRT Lead10. Judgment by the Investigator that the patient is unsuitable to participate in the trial and/or the patient is unlikely to comply with trial procedures, restrictions and requirements


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St. James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • Western General Hospital
    Crewe Road South Edinburgh
    Lothian
    EH4 2XU
  • The Christie
    550 Wilmslow Road Withington
    Manchester
    M20 4BX
  • Uclh
    250 Euston Road
    London
    NW1 2PQ
  • The Royal Marsden Hospital (london)
    Fulham Road
    London
    SW3 6JJ
  • The Royal Marsden Hospital (Sutton)
    Downs Road
    Sutton
    SM2 5PT

There is no guarantee that patients will benefit directly from taking part in this trial. SBRT is given with the aim of shrinking cancer and/or delaying time to cancer worsening. The aim of this trial is to find out whether SBRT is helpful in the treatment of recurrent or metastatic ovarian cancer and if treatment with SBRT either with or without Niraparib, may help increase the length of time before patients need to start a different treatment such as chemotherapy, as this is not currently known. The information gained from this trial may help in the treatment of patients with recurrent or metastatic ovarian cancer in the future.
Patients randomised to cohort 1 will be required to undergo additional blood tests, blood pressure and heart rate assessments to comply with the safety requirements for niraparib. All other visits will be in line with standard of care visits. The visit schedule and the assessments that will take place at each visit are explained in the SOPRANO patient information sheet. Patients' GPs will be informed of their participation in the trial.
Patients will have regular blood tests which may cause discomfort, bruising, bleeding or, rarely, infection. We have coordinated research blood collections alongside the mandatory safety blood tests which will help minimise the discomfort and ensure the safety of patients. All blood draws are completed before the patient receives treatment.
As part of the patient’s involvement in this study they will undergo CT/MRI/PET CT scans every 8 weeks (scan modality is not mandated, but sites are asked to ensure the same modality is used at each time point). The x-rays used for CT/PET CT scans mean that they will be exposed to ionising radiation. There is a small increased risk from any radiation dose of inducing cancer several years after exposure. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The current clinical condition of SOPRANO patients means the chance of this happening is extremely small. There is no radiation risk from MRIs.
Niraparib has been or is currently under evaluation as a single agent or in combination with other anticancer therapies in Phase 1 through Phase 3 clinical studies and has included over 1600 participants in studies of ovarian cancer. Niraparib is licensed in Europe including UK for the following indications:
• as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
• as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
A joint Independent Data Monitoring and Steering Commitee (IDMSC) will be set up for the SOPRANO trial. The IDMSC will meet regularly to review safety and assess the adverse events of all patients on trial. All patients will be encouraged to inform their clinician if they are experiencing any ill effects, whether they think it is related to the trial treatment or not. Investigators will be kept informed of any emerging safety data that may impact their patients' participation in the trial as the sponsors becomes aware of it.
The dose and fractionation schedule of SBRT treatment will be in accordance with the UK SABR consortium guidelines for each site of metastases. The NCRI Radiotherapy Trials Quality Assurance (RTTQA) group will oversee the quality assurance of the SBRT delivered within the trial to ensure the safety and consistency of radiotherapy delivery at participating centres. Prior to inclusion in the trial, individual centres will need to demonstrate they have robust procedures in place to ensure high-quality RTTQA planning and delivery guidelines will be met. During recruitment and prior to any repeat SBRT treatment, prospective review will be performed for all patients.

Prof Judith Bliss
+44 (0)203 4376647
soprano-icrctsu@icr.ac.uk


Prof Susana Banerjee
+44 (0)20 8661 3463
susana.banerjee@rmh.nhs.uk


Mrs Lorna Smith
+44 (0)20 3437 6647
soprano-icrctsu@icr.ac.uk



The study is sponsored by Institute of Cancer Research Clinical Trial & Statistics Unit and funded by GlaxoSmithKline.



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Read full details for Trial ID: ISRCTN13282459

Or CPMS 54603

Last updated 01 July 2024

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